Regeneron

Could safety scupper Ionis, Pfizer’s cholesterol drug vupanorsen?

Ionis has reported phase 2b trial data for its Pfizer-partnered antisense drug vupanorsen for cholesterol lowering that showed it met its main efficacy targets, but raised a few safety concerns as well. The top-line results of the TRANSLATE-TIMI 70 study – in dyslipidaemia patients with elevated non-HDL cholesterol and triglycerides – showed that vupanorsen was …

Could safety scupper Ionis, Pfizer’s cholesterol drug vupanorsen? Read More »

Vaccibody rebrands as Nykode, and unveils big Regeneron partnership

Norwegian biotech Vaccibody has changed its name to Nykode Therapeutics, and celebrated its new identity with a sizeable deal with Regeneron to develop vaccines for cancer and infectious diseases. The Oslo-based company is getting $50 million upfront from Regeneron – split between cash and an equity investment – with another $875 million on the table …

Vaccibody rebrands as Nykode, and unveils big Regeneron partnership Read More »

Merck’s oral PCSK9 drug matches injectables in early trials

Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with an oral alternative. MK-0616 has been shown to reduce LDL cholesterol by a similar margin to injectables sold by Amgen and Sanofi/Regeneron – as well as Novartis’ longer-lasting RNAi therapy …

Merck’s oral PCSK9 drug matches injectables in early trials Read More »

PharmaShots Weekly Snapshots (November 08 – 12, 2021)

Eisai Presents Results of Lecanemab in P-IIb Study 201 Study for the Treatment of Alzheimer’s Disease at CTAD 2021 Published: Nov 12, 2021 | Tags: Eisai, Lecanemab, P-IIb, Study 201 Study, Alzheimer’s Disease, CTAD 2021 Novo Nordisk’s Wegovy (semaglutide) Receives CHMP’s Recommendation for Approval to Treat Obesity Published: Nov 12, 2021 | Tags: Novo Nordisk, …

PharmaShots Weekly Snapshots (November 08 – 12, 2021) Read More »

COVID antibodies from Roche, Celltrion backed for approval in EU

The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to be backed for full approval in the EU. Ronapreve (casirivimab and imdevimab) – developed and distributed by Regeneron as REGN-COV in the US – has been recommended by the CHMP …

COVID antibodies from Roche, Celltrion backed for approval in EU Read More »

Regeneron Reports Results of REGEN-COV (casirivimab and imdevimab) in P-III Study Against COVID-19

Shots: The P-III trial evaluates REGEN-COV (1200mg, SC) vs PBO in a ratio (1:1) in patients who lived in the same household with COVID-19 patients diagnosed within the prior 4 days. The trial is jointly run with NIAID The results showed an 81.6% reduction in risk of COVID-19 during a pre-specified follow-up period b/w 2-8mos. …

Regeneron Reports Results of REGEN-COV (casirivimab and imdevimab) in P-III Study Against COVID-19 Read More »

One dose of Regeneron’s COVID antibody protects for eight months

A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight months, according to new trial data. The results suggest that the REGEN-COV (casirivimab/imdevimab) antibody could play a key role in protecting people who do not mount a sufficiently strong immune …

One dose of Regeneron’s COVID antibody protects for eight months Read More »

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III Trial for the Treatment of Eosinophilic Esophagitis

Shots: The second P-III trial evaluates the efficacy and safety of Dupixent (300mg weekly) vs PBO in 240 patients aged ≥12yrs. with EoE for 24wks. The trial met its co-primary EPs i.e., reduction in disease symptoms from baseline (64% vs 41%); patients experienced a (23.78 vs 13.86 points) improvement on 0-84 DSQ scale & achieved …

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III Trial for the Treatment of Eosinophilic Esophagitis Read More »

FDA clears Roche’s Susvimo implant for eye disease wet AMD

Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to regular injections into the eye. Susvimo has the same active ingredient as Roche’s big-selling therapy Lucentis (ranibizumab), a VEGF inhibitor administered once a month that has been approved by the …

FDA clears Roche’s Susvimo implant for eye disease wet AMD Read More »

PharmaShots Weekly Snapshots (October 18 – 22, 2021)

LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, Tralokinumab, P-III, ECZTRA 6 Trial, Atopic Dermatitis Marinomed Biotech Signs a License Agreement with Luoxin to Commercialize Budesolv (budesonide nasal spray) in Greater China Published: 22 Oct, 2021 | Tags: …

PharmaShots Weekly Snapshots (October 18 – 22, 2021) Read More »

Dupixent scores a first in rare skin disease prurigo nodularis

Sanofi and Regeneron’s Dupixent has become the first biologic drug to show activity in prurigo nodularis (PN), raising the hope of a new treatment option for the rare and highly debilitating skin disease. The two companies are still waiting for the results of a second phase 3 trial, due in the first half of next …

Dupixent scores a first in rare skin disease prurigo nodularis Read More »

Regeneron and Sanofi’s Dupixent (dupilumab) Receive the US FDA’s Approval as an Add-On Maintenance Treatment to Treat Moderate-To-Severe Asthma

Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The results showed a 65% avg. reduction in the rate of severe asthma attacks @1yrs.; improvement in lung function by 5.32% points @ 12wks. & as early as 2wks. & sustained …

Regeneron and Sanofi’s Dupixent (dupilumab) Receive the US FDA’s Approval as an Add-On Maintenance Treatment to Treat Moderate-To-Severe Asthma Read More »

NICE changes stance on Sanofi’s Dupixent for severe asthma

18 months after saying “no”  to regular NHS funding for Sanofi and Regeneron’s Dupixent (dupilumab) for severe asthma in initial guidance, NICE has now backed the drug. The final appraisal document for Dupixent (dupilumab) has given the green light to use of the drug as an add-on maintenance therapy for people aged over 12 with …

NICE changes stance on Sanofi’s Dupixent for severe asthma Read More »

PharmaShots Weekly Snapshots (October 11 – 15, 2021)

Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & …

PharmaShots Weekly Snapshots (October 11 – 15, 2021) Read More »

Regeneron Reports the US FDA’s Acceptance of Priority Review for REGEN-COV for the Treatment and Prophylaxis of COVID-19

Shots: The US FDA has accepted for priority review a BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals The BLA is based on P-III study assessing efficacy & safety of REGEN-COV to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in …

Regeneron Reports the US FDA’s Acceptance of Priority Review for REGEN-COV for the Treatment and Prophylaxis of COVID-19 Read More »

PharmaShots Weekly Snapshots (September 27 – October 01, 2021)

BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, …

PharmaShots Weekly Snapshots (September 27 – October 01, 2021) Read More »

Regeneron Publishes the Results of REGEN-COV (casirivimab and imdevimab) in P-III Trial for COVID-19 in NEJM

Shots: The P-III trial evaluates the efficacy and safety of REGEN-COV (casirivimab and imdevimab, 1200/2400mg) vs PBO in a non-hospitalized patient with COVID-19 The trial met its 1EPs & 2EPs i.e., 70% reduction in the risk of hospitalization or death in high-risk non-hospitalized patients & the safety profile was consistent with a previously reported data …

Regeneron Publishes the Results of REGEN-COV (casirivimab and imdevimab) in P-III Trial for COVID-19 in NEJM Read More »

ViewPoints Interview: Dr. Ahmet Sezer, Karl Lewis, and Regeneron’s Israel Lowy Share Insights on Libtayo (cemiplimab) for NSCLC & BCC

In an interview with PharmaShots, Dr. Ahmet Sezer, (Professor in the Department of Medical Oncology at Başkent University), Karl Lewis (Professor in the Division of Medical Oncology at the University of Colorado) and Israel Lowy (Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron) shared their views on the EC’s approval of Libtayo for …

ViewPoints Interview: Dr. Ahmet Sezer, Karl Lewis, and Regeneron’s Israel Lowy Share Insights on Libtayo (cemiplimab) for NSCLC & BCC Read More »

PharmaShots Weekly Snapshots (September 20 – 24, 2021)

Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results …

PharmaShots Weekly Snapshots (September 20 – 24, 2021) Read More »

ESMO21: Libtayo extends survival in first-line NSCLC, challenging Keytruda

There’s no shortage of cancer immunotherapies trying to knock Merck & Co’s Keytruda off the top of the tree in previously-untreated non-small cell lung cancer (NSCLC). Sanofi and Regeneron have reported new data for Libtayo that suggests the drug could be a contender. Libtayo (cemiplimab) given in combination with chemotherapy looks broadly to have matched …

ESMO21: Libtayo extends survival in first-line NSCLC, challenging Keytruda Read More »

EU panel rejects Pfizer’s tanezumab for osteoarthritis pain

Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor (NGF) inhibitor tanezumab looks to have been dashed after the EMA’s human medicines committee rejected the drug. A positive recommendation was already looking like a long shot for after FDA advisors voted 15 to one against approval of the …

EU panel rejects Pfizer’s tanezumab for osteoarthritis pain Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

Sanofi and Regeneron’s Dupixent Meets All Endpoints in P-III Study in Children with Atopic Dermatitis

Shots: The P-II/III LIBERTY AD PRESCHOOL (part B) involves assessing the efficacy & safety of Dupixent (200/300mg) + low-potency TCS vs TCS alone in 162 children aged 6mos. to 5 years with uncontrolled mod. to sev. AD Result: clear or almost-clear skin (28% vs 4%); 75% or greater overall disease improvement (53% vs 11%); improvement …

Sanofi and Regeneron’s Dupixent Meets All Endpoints in P-III Study in Children with Atopic Dermatitis Read More »

PROVENT trial puts AZ COVID antibody combo back on track

AstraZeneca’s AZD7442 has shown that it can prevent COVID-19 infection when given to healthy patients – the first time this has been demonstrated by a long-acting antibody-based drug. The results of the almost 5,200-patient PROVENT study show that pre-exposure prophylaxis using the antibody combination reduced the risk of developing symptomatic COVID-19 by 77% compared to …

PROVENT trial puts AZ COVID antibody combo back on track Read More »

Novartis says trials back Beovu safety in diabetic eye disease

There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the big question facing the company is whether it is less safe. Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on …

Novartis says trials back Beovu safety in diabetic eye disease Read More »

Novartis says trials back Beovu safety in diabetic eye disease

There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the big question facing the company is whether it is less safe. Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on …

Novartis says trials back Beovu safety in diabetic eye disease Read More »

Look out Dupixent, Lilly’s lebrikizumab is on the march

Eli Lilly had a lot riding on its two phase 3 trials of IL-13 inhibitor lebrikizumab in atopic dermatitis (AD) – and it now looks like it has backed a winner. The company has claimed across-the-board wins against primary and secondary measures of efficacy in the studies, and while the data hasn’t been revealed yet, …

Look out Dupixent, Lilly’s lebrikizumab is on the march Read More »

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)

Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to Develop Allogeneic Cell Therapies for the Treatment of Cancer Published: Aug 6, 2021 | Tags: Kite, Appia, Allogeneic Cell Therapies, Cancer Polpharma & Bioeq Report BLA Submission to the US …

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021) Read More »

Sanofi, Regeneron eye Libtayo challenge to Keytruda in first-line lung cancer

Sanofi and Regeneron’s latecomer checkpoint inhibitor Libtayo has largely been protected from heavyweight competition in its first niche markets, but now looks set to for a toe-to-toe contest with Merck & Co’s class leader Keytruda in the big non-small cell lung cancer (NSCLC) category. Keytruda (pembrolizumab) dominates first-line NSCLC treatment, where it is approved both …

Sanofi, Regeneron eye Libtayo challenge to Keytruda in first-line lung cancer Read More »

PharmaShots Weekly Snapshots (July 26 – 30, 2021)

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | …

PharmaShots Weekly Snapshots (July 26 – 30, 2021) Read More »

FDA starts review of Roche’s eye disease drug, setting up 2022 verdict

The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy …

FDA starts review of Roche’s eye disease drug, setting up 2022 verdict Read More »

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III LIBERTY CUPID Clinical Program for Chronic Spontaneous Urticaria

Shots: The study A of P-III LIBERTY CUPID trial evaluates Dupixent vs SoC in 138 patients aged ≥6 yrs. with CSU who remained symptomatic despite antihistamine use and who were not previously treated with anti-IgE therapeutics The trial met its 1EPs & 2EPs @24wks. i.e. showed a reduction in itch severity (63% vs 35%), reduction …

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III LIBERTY CUPID Clinical Program for Chronic Spontaneous Urticaria Read More »

Regeneron, AZ team up on drugs for obesity “superpower” gene

AstraZeneca has formed a partnership with Regeneron to investigate the potential of treating obesity using drugs directed at GPR75, a protective gene identified by scientists at the Regeneron Genetics Centre. AZ’s buy into the programme comes a few weeks after Regeneron published findings in the journal Science suggesting that people with certain GPR75 mutations have …

Regeneron, AZ team up on drugs for obesity “superpower” gene Read More »

AstraZeneca and Regeneron Collaborate to Research, Develop and Commercialize Therapies for Obesity

Shots: The companies collaborated to research, develop & commercialize small molecules directed against the GPR75 target with the potential to treat obesity and related co-morbidities The collaboration builds on the findings from the Regeneron Genetics Center of rare genetic mutations in the GPR75 gene associated with protection against obesity and on early joint research initiated …

AstraZeneca and Regeneron Collaborate to Research, Develop and Commercialize Therapies for Obesity Read More »

Regeneron’s Ronapreve Antibody Cocktail (casirivimab and imdevimab) Receives MHLW’s Approval for the Treatment of Mild to Moderate COVID-19

Shots: The approval is based on the results from a P-III trial evaluating Ronapreve (casirivimab and imdevimab) in high-risk non-hospitalized patients with COVID-19 The results showed a reduction in the risk of hospitalization or death by 70% in addition to the results from a P-I trial that demonstrated the safety, tolerability & PK in Japanese …

Regeneron’s Ronapreve Antibody Cocktail (casirivimab and imdevimab) Receives MHLW’s Approval for the Treatment of Mild to Moderate COVID-19 Read More »

PharmaShots Weekly Snapshots (June 14 – 18, 2021)

Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, Amasa Therapeutics, Clinical-Grade Hystem BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Published: June 18, 2021 | Tags: BioNTech, P-II, Clinical Trial, BNT111, …

PharmaShots Weekly Snapshots (June 14 – 18, 2021) Read More »

Regeneron Reports Results of REGEN-COV (casirivimab and imdevimab) in P-III RECOVERY Trial for COVID-19 Patients

Shots: The P-III RECOVERY trial evaluating REGEN-COV (8,000 mg) vs usual care alone in seronegative patients with COVID-19 demonstrates 20% reduction in risk of death in patients failing to exhibit a natural antibody response The 1EPs showed 20% reduction in all-cause mortality, no longer significant effect on 28-day mortality on combining larger seropositive group (also …

Regeneron Reports Results of REGEN-COV (casirivimab and imdevimab) in P-III RECOVERY Trial for COVID-19 Patients Read More »

Regeneron drug saves lives in severe COVID-19, but it’s not for all

People who cannot generate an effective immune response against COVID-19 can be protected with an infusion of Regeneron’s antibody therapy REGN-COV, according to new data from the UK RECOVERY trial. The therapy significantly reduced the risk of death, the length of hospital stay and the need for a ventilator in the study, which involved around …

Regeneron drug saves lives in severe COVID-19, but it’s not for all Read More »

Amgen pays Kyowa $400m upfront for OX40 eczema drug

Amgen has made a play in a hot area of immunology R&D, paying $400 million upfront to claim rights to an OX40-targeting drug from Kyowa Kirin that is ready for phase 3 testing for atopic dermatitis or eczema.  The deal gives Amgen rights to the KHK4083 antibody in all countries except Kyowa’s home market of …

Amgen pays Kyowa $400m upfront for OX40 eczema drug Read More »

Novartis halts three trials of Beovu eye drug on safety concerns

Prospects for Novartis’ ophthalmology drug Beovu have taken another dive after the drugmaker reported toxicity issues in a new phase 3 trial in wet age-related macular degeneration (AMD). On the plus side, Beovu (brolucizumab) met its efficacy objectives in the MERLIN study, but that was offset by higher rates of inflammatory reactions in the eyes …

Novartis halts three trials of Beovu eye drug on safety concerns Read More »

PharmaShots Weekly Snapshots (May 24 – 28, 2021)

Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation,  Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure …

PharmaShots Weekly Snapshots (May 24 – 28, 2021) Read More »

Regeneron Receives CHMP’s Positive Opinion Recommending the Approval of Libtayo (cemiplimab) for NSCLC and BCC

Shots: The CHMP recommended the approval of Libtayo as a 1L treatment for adults with NSCLC expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations, based on the P-III EMPOWER-Lung 1 study The positive opinion of Libtayo in LA and mBCC is based on P-II EMPOWER-BCC 1 study in patients …

Regeneron Receives CHMP’s Positive Opinion Recommending the Approval of Libtayo (cemiplimab) for NSCLC and BCC Read More »

PharmaShots Weekly Snapshots (May 17 – 21, 2021)

BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 | Tags: BeiGene, Tislelizumab, CT, P-III, RATIONALE 309 Study, Recurrent, Metastatic Nasopharyngeal Cancer Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR …

PharmaShots Weekly Snapshots (May 17 – 21, 2021) Read More »

Regeneron and Sanofi Present Results of Dupixent (dupilumab) in P-III VOYAGE Study for Asthma at ATS 2021

Shots: The P-III VOYAGE trial involves assessing Dupixent (100/200mg, q2w, based on weight) + SOC asthma therapy in 408 children aged 6-11yrs. with uncontrolled mod. to-sev. asthma with evidence of type 2 inflammation Results: improvement in asthma control @24wks. (1.34/ 1.33 vs 0.88/ 1.00); improvement in ACQ-7-IA; reduction in mean FeNO levels to below the …

Regeneron and Sanofi Present Results of Dupixent (dupilumab) in P-III VOYAGE Study for Asthma at ATS 2021 Read More »

PharmaShots Weekly Snapshots (May 10 – 14, 2021)

AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | Tags: AzurRx BioPharma, P-II, MS1819, PERT, Cystic Fibrosis, Severe, Exocrine Pancreatic Insufficiency Goldfinch Bio Initiates P-I Clinical Trial of GFB-024 for the Treatment of Severe Insulin Resistant Diabetic Nephropathy Published: …

PharmaShots Weekly Snapshots (May 10 – 14, 2021) Read More »

Regeneron and Sanofi Present Positive Results of Libtayo (cemiplimab) from P-III Trial for Cervical Cancer at ESMO2021

Shots: The P-III trial involves assessing libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based CT. The companies expect the regulatory submission in 2021 The results demonstrated a 31% reduction in the risk of death in the total population, improvement in OS, PFS, …

Regeneron and Sanofi Present Positive Results of Libtayo (cemiplimab) from P-III Trial for Cervical Cancer at ESMO2021 Read More »

Scotland opens door to Translarna for Duchenne muscular dystrophy

A disparity in UK access to a medicine for Duchenne muscular dystrophy (DMD) has been addressed, after Scotland gave a green light to use of PTC Therapeutics’ Translarna for the first time.  The Scottish Medicines Consortium (SMC) says that Translarna (ataluren) can be provided by NHS Scotland for a period of three years, once PTC …

Scotland opens door to Translarna for Duchenne muscular dystrophy Read More »

Regeneron to ask FDA to use antibody to prevent COVID-19

Regeneron is to ask the FDA for clearance to use its antibody cocktail as a preventive treatment for COVID-19. The therapy is already authorised by the FDA for adults with mild-to-moderate disease and paediatric patients at least 12 years of age who have tested positive for the virus and are at high risk of serious …

Regeneron to ask FDA to use antibody to prevent COVID-19 Read More »

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021)

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, Under 12 Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases Published: Mar 26, 2021 | Tags: Tetra Bio-Pharma, Initiates, Additional Studies, ARDS-003,  Neuroinflammation, Antiviral Diseases Immunai …

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021) Read More »

Regeneron’s antibody cocktail cuts COVID hospitalisation in large trial

Regeneron has posted findings from a large trial its COVID-19 antibody cocktail showing it reduced risk of hospitalisation or death by 70%. The US pharma said that the results were a landmark as they “conclusively” demonstrated that REGEN-COV (casirivimab+imdevimab) can significantly reduce death in an outpatient setting. Data from the phase 3 trial will also …

Regeneron’s antibody cocktail cuts COVID hospitalisation in large trial Read More »

Regeneron Reports Results of REGEN-COV Antibody Cocktail in P-III Trial to Prevent COVID-19

Shots: The P-III trial involves assessing REGEN-COV (casirivimab & imdevimab, 1200/2400mg, IV) vs PBO in non-hospitalized patients with COVID-19 The trial met its 1EPs i.e. showed a reduction in the risk of hospitalization and death with both doses by 70% /71% respectively and met its 2EPs including the ability to reduce symptom duration. The P-II …

Regeneron Reports Results of REGEN-COV Antibody Cocktail in P-III Trial to Prevent COVID-19 Read More »

The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US …

The US FDA New Drug Approvals in February 2021 Read More »

The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US …

The US FDA New Drug Approvals in February 2021 Read More »

Sanofi, Regeneron prep filings for Libtayo in cervical cancer

Sanofi and Regeneron’s checkpoint inhibitor Libtayo has become the first immunotherapy to improve survival when used as a second-line therapy in cervical cancer, setting up regulatory filings later this year. A phase 3 trial of the PD-1 inhibitor in cervical cancer patients who had progressed after first-line chemotherapy has been stopped early after an interim …

Sanofi, Regeneron prep filings for Libtayo in cervical cancer Read More »

Regeneron and Sanofi Report Results of Libtayo (cemiplimab) in P-III Trial for Cervical Cancer

Shots: The P-III trial involves assessing Libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based CT. The trial enrolled patients regardless of their PD-L1 status The results demonstrated a 31% reduction in the risk of death in the total population, improvement in OS, …

Regeneron and Sanofi Report Results of Libtayo (cemiplimab) in P-III Trial for Cervical Cancer Read More »

ExeVir ready for clinic with variant-targeting llama antibody

Last year, Belgium’s ExeVir Bio raised 23 million euros ($27 million) to finance development of llama antibodies – and now it is ready to begin clinical development of a potential treatment that could be effective against emerging COVID-19 variants. Regeneron and Eli Lilly have already got antibody therapies on the market following emergency approvals by …

ExeVir ready for clinic with variant-targeting llama antibody Read More »

EMA backs emergency use of Lilly’s COVID antibodies

The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, clearing the way for use in EU member states. The CHMP says bamlanivimab (LY-CoV555) can be given alone or administered together with etesevimab (LY-CoV016) to treat at-risk patients aged 12 …

EMA backs emergency use of Lilly’s COVID antibodies Read More »

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly and Incyte, Report, Results, Olumiant (baricitinib), P-III, BRAVE-AA2, Study, Severe, Alopecia Areata Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Published: Mar 5, 2021 | Tags: …

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021) Read More »

Lilly’s Olumiant is first JAK drug backed by NICE for eczema

Eli Lilly’s JAK inhibitor Olumiant has become the first drug in the JAK inhibitor class to be recommended for NHS use in England and Wales as a treatment for atopic dermatitis, also known as eczema. Olumiant (baricitinib) has been backed by cost-effectiveness agency NICE  to treat moderate to severe atopic dermatitis in adults who haven’t …

Lilly’s Olumiant is first JAK drug backed by NICE for eczema Read More »

Regeneron’s Ab Cocktail (casirivimab + imdevimab) Receives the CHMP’s Positive Opinion to Treat COVID-19

Shots: The EMA’s CHMP has recommended the use of casirivimab + imdevimab in patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19 The CHMP scientific opinion supports national decision making within EU states on the use of the antibodies, prior to the future …

Regeneron’s Ab Cocktail (casirivimab + imdevimab) Receives the CHMP’s Positive Opinion to Treat COVID-19 Read More »

PharmaShots Weekly Snapshots (Feb 22- 26, 2021)

Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, IDMC, Clearance, Efficacy, REGEN-COV (Casirivimab + Imdevimab), P-III, COVID-19, Outpatient, Outcomes, Trial Daiichi Sankyo Collaborates with LYSA-LYSARC-CALYM for Valemetostat in Patients with R/R B-Cell Lymphoma Published: Feb 26, 2021 | …

PharmaShots Weekly Snapshots (Feb 22- 26, 2021) Read More »

Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial

Shots: Regeneron reported changes to the P-III study assessing REGEN-COV in non-hospitalized patients with COVID-19, following recommendations from the IDMC The IDMC found clear clinical efficacy in reducing the rate of hospitalization and death with both doses (1,200 & 2,400 mg) of REGEN-COV vs PBO. The company will immediately stop enrolling patients in the PBO …

Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Read More »

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

Shots: The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the 1L treatment with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or ROS1 aberrations The study showed a 32% reduction in the …

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC Read More »

PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)

Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, US, FDA, EUA, Use, CLIA, Waived, Settings Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Published: Feb 12, 2020 | Tags: Takeda, Collaborates, Ensoma, Accelerate, Next-Generation, Vivo Gene …

PharmaShots Weekly Snapshots (Feb 08 – 12, 2021) Read More »

Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia

Shots: The approval is based on P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg, IV, q4w) + vs PBO in 65 patients aged ≥12yrs. with HoFH for 24wks. The study met 1EPs i.e. 49% reduction in LDL-C (47% vs 2%), patients also experienced a reduction in the level of ApoB, non-HDL-C. Reductions in LDL-C …

Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia Read More »

FDA grants emergency licence for Lilly’s COVID-19 antibody combo

The FDA has granted an emergency licence for Eli Lilly’s COVID-19 antibody combination therapy, to reduce chances of high-risk patients progressing from mild to moderate disease to more severe symptoms that may need hospital treatment. The FDA granted an Emergency Use Authorization (EUA) covering patients aged 12 years and over for investigational bamlanivimab (LY-CoV555) 700 …

FDA grants emergency licence for Lilly’s COVID-19 antibody combo Read More »

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma

Shots: The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or distant) Results: median follow-up (9.5 & 15.1mos.); ORR (21% & 29%); PR (21% & 23%); D0R @≥6mos. (100% & 79%); with longer follow up, 0RR with LA BCC (31%) as …

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma Read More »

UK patient group warns COVID could limit access to Novartis’ new eye drug

NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access could be limited until the pandemic recedes because of disruption to ophthalmology clinics. In final guidance NICE said trials have shown Novartis’ Beovu has similar efficacy in wet advanced macular …

UK patient group warns COVID could limit access to Novartis’ new eye drug Read More »

PharmaShots Weekly Snapshots (Jan 25- 29, 2021)

Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, Develop, Quantum Algorithm, Drug, Discovery, Development Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations Published: Jan 29, 2020 …

PharmaShots Weekly Snapshots (Jan 25- 29, 2021) Read More »

Regeneron’s REGEN-COV Antibody Cocktail Confirms its Effectiveness Against UK and South Africa SARS-CoV-2 Variants

Shots: REGEN-COV neutralizes the SARS-CoV-2 B.1.1.7 variants, identified in the UK & SA. The data was included in a bioRxiv paper and submitted for peer-reviewed publication on the changing resistance of SARS-CoV-2 variants to Ab neutralization REGEN-COV retained its neutralizing capability against the B.1.1.7 variant. The Ab cocktails also retained its potency against the B.1.351 …

Regeneron’s REGEN-COV Antibody Cocktail Confirms its Effectiveness Against UK and South Africa SARS-CoV-2 Variants Read More »

Regeneron and Lilly post new data backing COVID antibody cocktails

Regeneron is considering an emergency filing for its antibody cocktail REGEN-COV to protect people against COVID-19 after early trial results showed it conferred 100% protection against symptomatic infection. The announcement came after Eli Lilly posted results from its rival antibody cocktail, showing hospitalisations were reduced by 70% in high-risk patients. Regeneron’s results are based on …

Regeneron and Lilly post new data backing COVID antibody cocktails Read More »

Regeneron Reports Results of REGEN-COV Antibody Cocktail Used as Passive Vaccine to Prevent COVID-19

Shots: The ongoing P-III trial involves assessing REGEN-COV (casirivimab & imdevimab) in 2000+ participants used as a passive vaccine to prevent COVID-19. An exploratory analysis, conducted on the first ~400 individuals, randomized to receive passive vaccination with REGEN-COV (1200mg, SC) vs PBO Reduction in overall infections seen within 1st week with 100% prevention of symptomatic …

Regeneron Reports Results of REGEN-COV Antibody Cocktail Used as Passive Vaccine to Prevent COVID-19 Read More »

PharmaShots’ Key Highlights of Fourth Quarter 2020

The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated …

PharmaShots’ Key Highlights of Fourth Quarter 2020 Read More »

The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19

Shots: Roche confirms that the US govt. will purchase additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed The agreement additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed. The cocktail has received the US FDA’s EUA …

The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19 Read More »

PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, …

PharmaShots Weekly Snapshots (Dec 28- 31, 2020) Read More »

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

Shots: The company reported encouraging initial data from an ongoing P-I/II/III trial of its casirivimab + imdevimab (8,000/2,400mg) in hospitalized COVID-19 patients requiring low-flow oxygen. The results passed the futility analysis as seronegative patients treated with the Ab cocktail had a lower risk of death or receiving mechanical ventilation In seronegative patients, the cocktail reduced …

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen Read More »

EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed

UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed. Hertfordshire-based EUSA said recruitment has begun in phase 3 trial involving patients with COVID-19 previously treated with corticosteroids and other respiratory viruses associated with serious …

EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed Read More »

Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps

Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck. The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps …

Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps Read More »

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, …

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) Read More »

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Shots: Penn allied with Regeneron to investigate Ab cocktail (casirivimab & imdevimab) to prevent COVID-19 infection when delivering intranasally via AAV vectors The collaboration b/w Wilson and Penn’s GTP and Regeneron will have two phases. The first phase will include the validation of the effectiveness of Abs delivered via AAV in a large animal model …

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform Read More »

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test PostEra Collaborates …

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020) Read More »

Regeneron’s COVID-19 antibody cocktail gets US emergency licence

Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become available. The cocktail of casirivimab and imdevimab is still being investigated in trials but the FDA has enough data to grant a temporary licence while the pandemic continues. Formerly known …

Regeneron’s COVID-19 antibody cocktail gets US emergency licence Read More »

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Shots: The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric patients aged ≥12yrs. weighing at least 40kg [~88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 The EUA …

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19 Read More »

Insights+: The US FDA New Drug Approvals in October 2020

The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 90 novel products so far in 2020, including 5 in Oct 2020. …

Insights+: The US FDA New Drug Approvals in October 2020 Read More »

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke Novo Nordisk to Acquire Emisphere Technologies for $1.8B Published: Nov 6, …

PharmaShots Weekly Snapshot (Nov 02-06, 2020) Read More »

Regeneron’s COVID-19 antibody cocktail therapy hits safety problem

Regeneron’s coronavirus antibody cocktail therapy against COVID-19, famously used to treat president Donald Trump, has hit a safety issue after independent safety experts recommended it should not be given to high-risk patients in a late-stage clinical trial. It’s the latest blow for antibody therapies against COVID-19 after Eli Lilly last week announced it won’t resume …

Regeneron’s COVID-19 antibody cocktail therapy hits safety problem Read More »

Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Shots: Regeneron pauses dosing of the garetosmab (REGN2477) in the ongoing P-II LUMINA-1 study in patients with FOP. The pause is due to fatal serious AEs in the study during the open-label extension during which all patients received active treatment Regeneron shared the update with the trial’s IDMC and regulatory authorities and will conduct a …

Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva Read More »

FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda

The FDA has started a priority review of Regeneron and Sanofi’s checkpoint inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC), based on data they hope will carve out a niche for the drug in a highly-contested market. PD-1 inhibitor Libtayo (cemiplimab) impressed oncologists earlier this year with results from a trial in previously-untreated NSCLC …

FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda Read More »

Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting

Shots: The P-ll/lll trial involves assessing of REGN-COV2 (8gm/2.4gm) + SOC vs PBO + SOC in 524 patients with mild-to-moderate COVID-19 in an outpatient setting The study met its 1EPs & 2EPs demonstrating a reduction in viral load and patient medical visits. Moreover, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical …

Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting Read More »

Sanofi and Regeneron Report Results of Dupixent (dupilumab) in Part A of P-lll Study for Eosinophilic Esophagitis (EoE)

Shots: Part A of P-lll study involves assessing of Dupixent (qw, 300mg) vs PBO in 81 patients aged≥ 12 yrs. with EoE. The study resulted in meeting its co-primary and all key 2EPs, presented at the virtual ACG 2020 and UEG Week 2020 Results: Patients reported significant improvement on DSQ as 4 wks. and continued …

Sanofi and Regeneron Report Results of Dupixent (dupilumab) in Part A of P-lll Study for Eosinophilic Esophagitis (EoE) Read More »

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis Published: Oct 15, …

PharmaShots Weekly Snapshot (Oct 12-16, 2020) Read More »

Regeneron’s antibody cocktail approved by FDA for Ebola

An antibody cocktail from Regeneron has been approved by the FDA as the first treatment for Ebola, offering hope that a similar approach could be used to combat COVID-19. The FDA approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for treatment of infection caused by Zaire ebolavirus in adults and children including newborns of mothers who test …

Regeneron’s antibody cocktail approved by FDA for Ebola Read More »

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Shots: The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the …

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola Read More »

Regeneron Seeks the US FDA’s EUA for REGN-COV2 Antibody Combination to Treat COVID-19

Shots: Regeneron has submitted a request to the US FDA seeking EUA for its REGN-COV2 investigational Ab regimen to treat COVID-19. If EUA is granted, the US govt. has committed to making REGN-COV2 available in the US at no cost and would be responsible for its distribution The company reported that there are doses available …

Regeneron Seeks the US FDA’s EUA for REGN-COV2 Antibody Combination to Treat COVID-19 Read More »

Regeneron joins Lilly in seeking emergency OK for COVID-19 antibody

Regeneron has followed Eli Lilly in asking the FDA for emergency approval of its COVID-19 antibody therapy, shortly after the drug was thrust into the spotlight by being used to treat President Trump. The request for emergency use authorization (EUA) for REGN-COV2 comes amid a spike in interest about antibodies against the SARS-CoV-2 coronavirus, driven …

Regeneron joins Lilly in seeking emergency OK for COVID-19 antibody Read More »

Lilly asks FDA for emergency clearance for COVID-19 antibody therapy

Eli Lilly has asked the FDA for an Emergency Use Authorization for its COVID-19 antibody therapy, after announcing new efficacy data from an ongoing trial. It’s been a big week for this class of therapies – Regeneron’s antibody cocktail was famously used to treat president Donald Trump’s illness and GlaxoSmithKline is expanding research into its …

Lilly asks FDA for emergency clearance for COVID-19 antibody therapy Read More »

GSK and Vir expand COVID-19 antibody trial after Trump’s treatment with Regeneron’s rival

GlaxoSmithKline and partner Vir Biotechnology are to expand a trial of an experimental antibody to treat COVID-19, putting heat on Regeneron’s rival that has been famously used to treat president Donald Trump. GSK and Vir began trials of the antibody on early-stage COVID-19 patients in August, with the aim of preventing symptoms from progressing. The …

GSK and Vir expand COVID-19 antibody trial after Trump’s treatment with Regeneron’s rival Read More »

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi 2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Published: Oct 1, 2020 | Tags: COVID-19, …

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020) Read More »

Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx …

Is COVID the Rx for the Pharmaceutical Industry’s Reputation? Read More »

Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2

Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that could more than triple supplies of the drug if it gets approved. Regeneron is already working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in …

Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2 Read More »

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Shots: The two global companies collaborated to develop, manufacture, and distribute REGN-COV2 across the globe. The agreement is expected to increase the supply of REGN-COV2 to at least 3.5 times the current capacity with the potential for expanding it further Regeneron will lead the distribution in the US while Roche will be responsible for the …

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19 Read More »

Regeneron’s cholesterol drug evinacumab claims February FDA date

The FDA has started a speedy review of Regeneron’s ANGPTL3-targeting antibody evinacumab for a rare, inherited disorder that dramatically raises the risk of heart disease. The cholesterol-lowering drug has been classed as a breakthrough therapy for homozygous familial hypercholesterolaemia (HoFH) by the FDA, which is due to deliver a decision on the marketing application by …

Regeneron’s cholesterol drug evinacumab claims February FDA date Read More »

Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Shots: The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline The expected PDUFA date for the therapy as Feb 11, 2021. The US FDA has granted BT designation …

Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH Read More »

Regeneron pairs with BioNTech on melanoma immunotherapy

Regeneron and Sanofi’s PD-1 inhibitor Libtayo will be tested in tandem with a cancer vaccine developed by BioNTech in melanoma in people who have failed treatment with other checkpoint inhibitors. The two companies will carry out a phase 2 trial of Libtayo (cemiplimab) alongside BioNTech’s mRNA cancer immunotherapy BNT111, which is designed to stimulate immune …

Regeneron pairs with BioNTech on melanoma immunotherapy Read More »

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected …

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020 Read More »

BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Shots: Regeneron will be responsible to deliver treatment doses for six years post-approval of product from the FDA, will receive compensation of ~$10M & average of $67M/year in 2021 and each for the next five years (2022-2026) respectively In 2019, the PALM trial evaluated REGN-EB3 vs ZMapp conducted in the Democratic Republic of the Congo, …

BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness Read More »